MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR VISION; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	NVRO-35
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 35mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using an unknown balloon.During the procedure, the imaging revealed the valve was in folded (palmito effect) so, it was removed from the patient's anatomy and a new 35mm, navitor vision valve was able to be implanted successfully.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.The patient was in a stable condition.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

• Brand Name: NAVITOR VISION
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24719447
• Report Number: 2135147-2026-02016
• Device Sequence Number: 6109705
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• UDI-Public: (01)05415067045768(17)271014
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NVRO-35
• Device Catalogue Number: NVRO-35
• Device Lot Number: 10590252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FNAV-DS-LG
• Patient Sex: Unknown